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Drug-Coated Stents

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What is a Stent?

A stent is a small, lattice-shaped, metal or plastic tube inserted permanently into an artery or blood vessel. A stent is used to open an artery that has become too narrow due to atherosclerosis, a condition in which plaque builds up on the artery's inner walls blocking blood flow. Stents are typically placed inside a coronary (heart) artery after a balloon angioplasty procedure in order to prevent "restenosis" or the re-closing or re-blocking of the artery.

In 2006, the FDA said that it has been closely monitoring drug-coated stents since they entered the U.S. market in 2003 and 2004, and will continue to do so. New data suggests there’s a small, but significant risk of stent thrombosis (blood clotting in the stent). However, the FDA doesn’t yet have enough information to draw any conclusions regarding the risk and causes of stent thrombosis.

The FDA believes that coronary drug-coated stents remain safe and effective when used for the FDA-approved indications. A public panel meeting of outside scientific experts was conducted to review all the data and to make recommendations about what steps should be taken. The FDA continues to look into any reported adverse events related to drug-coated stents.

In-stent restenosis (the inside of the stent becomes clogged) -- the risk is higher in those with non-drug-coated stents

Other rare complications of coronary stents include chest pain, heart attack, or tearing of the blood vessel.

Drug-coated stents may have additional risks. Ask your health care professional about the risks associated with stents and drug-coated stents.

When Should Drug-Coated Stents Not Be Used?

Drug-coated stents may not be advised for patients who have had recent heart surgery or women who are nursing or pregnant. Patients who receive a drug-coated stent may need anti-platelet drugs for at least several months.

Stents shouldn’t be used in patients who can’t tolerate angioplasty or who are sensitive (allergic) to the stent materials. They shouldn't be used in patients who can't be placed on blood-thinning (anti-platelet) medication.

The safety and effectiveness of a drug-coated stent have not been studied in patients who have a blockage in a heart bypass graft, who are actually having a heart attack, or who had previous intravascular radiation treatment.

Drug-coated stents have additional restrictions. Your health care professional can tell you more about whether you’re an appropriate candidate for this technology.

Getting Legal Help

A medical device manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of any known risks associated with its products. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the medical device, under product liability law.

If you or a loved one have had a drug-coated stent implanted and are experiencing any unusual health problems or medical conditions, you should contact your doctor immediately. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by a drug-coated stent.